Subchondroplasty for Treatment of Bone Marrow Edema in the Foot and Ankle

Last updated: October 4, 2024
Sponsor: Ellianne M. Nasser
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Subchondroplasty

Clinical Study ID

NCT03921489
2019-0221
  • Ages > 18
  • All Genders

Study Summary

The subchondroplasty procedure has been used to treat bone marrow edema mostly located in the periarticular region of the knee. In the past few years, it has expanded its use in the foot and ankle. There has, however, been very minimal research documented on its utilization in that area. This study aims to prospectively evaluate the course of treatment and outcomes of painful bone marrow lesions in these associated podiatric circumstances using subchondroplasty. It is hypothesized that use of calcium phosphate bone substitute in the foot and ankle to treat bone marrow edema will have more favorable short and long-term outcomes than joint destructive and joint sparing procedures more commonly performed for treatment in the past.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Bone marrow edema diagnosed on MRI

  • Pain in the foot and ankle due to the presence of bone marrow edema

  • Failed 3 months of conservative treatment

Exclusion

Exclusion Criteria:

  • Patient <18 years of age

  • Presence of osteomyelitis of poor surgical candidates due to comorbidities such asdiabetics with an HbA1c of >8%

  • Patient with previous foot and ankle surgeries that may interfere with futureoutcomes

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Subchondroplasty
Phase:
Study Start date:
June 04, 2021
Estimated Completion Date:
December 31, 2024

Study Description

The subchondroplasty procedure has been used to treat bone marrow edema mostly located in the periarticular region of the knee. In the past few years, it has expanded its use in the foot and ankle. There has, however, been very minimal research documented on its utilization in that area. Bone marrow edema arises from altered stresses on bones due to osteoarthritis, biomechanical abnormalities, coalitions, infection, and trauma. This study aims to prospectively evaluate the course of treatment and outcomes of painful bone marrow lesions in these associated podiatric circumstances using subchondroplasty. This should, therefore, expose this modality as a viable treatment option for bone marrow edema.

Patients will be evaluated in the office/clinic setting with a positive diagnosis of bone marrow edema confirmed via MRI. They must have failed 3 months of conservative treatment measures including, but not limited to, orthotic modifications, taping, immobilization or offloading, and anti-inflammatories. The study population includes individuals over the age of 18 with no significant comorbidities or previous foot and ankle surgical interventions. These patients will go on to have calcium phosphate mineral compound injected into the bone marrow lesions. We will track the progression of their symptoms and evaluate via Visual Analog Scale (VAS) pain score and the American Orthopedic Foot and Ankle Score (AOFAS) at 3-month, 6-month, and 1-year follow-ups.

The subchondroplasty procedure is a viable treatment option for bone marrow edema in the setting of altered pedal biomechanics, gait abnormalities, osteoarthritis, and trauma. It is a minimally invasive procedure that maximizes positive outcomes, allows the patient to be immediately weight bearing following surgery, and has short operating room times. This surgical procedure is a new and innovative technique introduced to the podiatric field that will allow the surgeon to intervene at an earlier stage in efforts to alleviate symptoms. It is hypothesized that use of calcium phosphate bone substitute in the foot and ankle to treat bone marrow edema will have more favorable short and long-term outcomes than joint destructive and joint sparing procedures more commonly performed for treatment in the past.

Connect with a study center

  • Geisinger Community Medical Center

    Scranton, Pennsylvania 18510
    United States

    Active - Recruiting

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